Medline Industries, LP is recalling 74 units of Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters. These devices may contain higher than expected amounts of bacterial endotoxin. No incidents or injuries have been reported to date; however, the presence of endotoxins can cause serious inflammatory reactions or infections during medical procedures. The affected items include several models sold in states including Arkansas, California, Texas, and Washington. Healthcare providers should immediately stop using these devices and contact the manufacturer for a return or replacement.
Exposure to bacterial endotoxins during an electrophysiology procedure can trigger a pyrogenic reaction, causing fever, chills, low blood pressure, and systemic inflammatory response syndrome (SIRS). This poses a significant health risk to patients undergoing cardiac catheterization.
Quantity affected: 74 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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